Teriflunomide
- Product NDC
- 70771-1011
- 11-digit product format
- 707711011
- Labeler code
- 70771
- Product ID
- 70771-1011_b7b4c7bb-e9d3-4441-a7d5-b949b1656e36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriflunomide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA209668
- Marketing category
- ANDA
- Marketing start
- 2023-02-14
- Substance
- TERIFLUNOMIDE
- Active strength
- 14 mg/1
- Pharmacologic classes
- Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Teriflunomide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERIFLUNOMIDE | 14 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1C058IKG3B |
| Rxcui | 1310525, 1310533 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1011-3 | Teriflunomide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 70771-1011-7 | Teriflunomide | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
| 70771-1011-7 | Teriflunomide | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 3 |
| 70771-1011-8 | Teriflunomide | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1011 | TERIFLUNOMIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, 4 package rows | 20240815_58991a51-d40e-476f-8f5f-ac89e68e7107.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1011-3 | 70771101103 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1011-3) | | 2023-02-14 | No | No | Current |
| 70771-1011-7 | 70771101107 | 1 in 1 CARTON | | | | | Historical |
| 70771-1011-8 | 70771101108 | 2 CARTON in 1 CARTON (70771-1011-8) / 1 BLISTER PACK in 1 CARTON (70771-1011-7) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 carton | 2023-02-14 | No | No | Current |